Case Study: Due Diligence Audit for a US Biotech Investor Evaluating a European Acquisition

Case Study Overview

For investors in biotech and biopharma, a Due Diligence Audit is essential to uncover hidden GMP and operational risks before acquisitions. Weak Quality Systems or unresolved compliance issues can significantly impact valuation and future scalability. This case study shows how GMP Bridge supported a U.S.-based biotech investor with an independent GMP due diligence audit of a European sterile biologics manufacturer, delivering clarity for investment decisions and negotiation leverage.

The Challenge

A U.S.-based biotech investor evaluating the acquisition of a European sterile biologics manufacturer required an independent, expert-led GMP due diligence audit. The goal was to uncover hidden risks, assess regulatory and operational maturity, and provide a clear picture of remediation needs and future scalability before finalizing the deal.

Quick Summary

Region: United States (Investor) / Europe (Target Company)
Company Type: US-based biotech investor evaluating a European sterile drug substance manufacturer
Products: Recombinant proteins and sterile intermediates

Solution Delivered

Conducted a comprehensive onsite due diligence audit covering Quality Systems, manufacturing operations, and supply chain.
Reviewed inspection history, deviation/CAPA processes, and contamination control practices.
Assessed batch release performance, Quality Oversight, and sterility assurance framework.
Identified hidden liabilities, remediation needs, and regulatory vulnerabilities.
Delivered a detailed due diligence report with risk categorization, remediation costs, and post-acquisition priorities.
Collaborated directly with legal and financial teams to integrate technical findings into valuation and negotiation strategies.

Impact and Results

Provided a clear risk profile and operational assessment of the target company.
Identified hidden liabilities and remediation costs impacting acquisition valuation.
Enabled informed investment decision-making and negotiation leverage.
Offered strategic recommendations for post-acquisition integration and operational improvements.

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